NCT00868517.
| Trial name or title | The effect of acupuncture on PTSD‐related insomnia |
| Methods | This is a randomised single‐blind trial comparing 3 treatment groups: acupuncture, sham acupuncture and no treatment, for patients with insomnia related to post‐traumatic stress disorder |
| Participants | Inclusion criteria: 1. Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts 2. Diagnosed with PTSD per DSM‐IV criteria 3. Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI) 4. Diagnosis of insomnia made after PTSD diagnosis 5. If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrolment in study Exclusion criteria: 1. Does not speak English 2. Not competent to sign informed consent 3. History of moderate or severe traumatic brain injury 4. Start use of CPAP or BiPAP during the study 5. Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation or psychosis 6. History of substance abuse dependence (as defined per DSM‐IV criteria) during the one year preceding enrolment in the study OR history of illicit substance use for 3 months prior to study enrolment OR positive Audit C score at study enrolment or during course of study enrolment (defined as score of 5 and above) 7. Received acupuncture during past 3 months 8. On Coumadin, heparin or Lovenox 9. Pregnancy |
| Interventions | Experimental: will receive true group ear acupuncture Sham comparator: will receive sham group ear acupuncture No intervention strict control group: will receive conventional care only |
| Outcomes | Primary outcome: Sleep quality rating as measured by Insomnia Severity Index and Morin Sleep diary (time frame: t = 0, 1, 2 months) Secondary outcomes: 1. Fragmented sleep patterns as measured by Morin Sleep Diary and Wrist Actigraphs (time frame: t = 0, 1, 2 months) 2. Hypnotic medication use (time frame:t = 0,1,2 months) 3. Attrition rates (time frame: t = 0, 1, 2 months) 4. Veteran Satisfaction Scores (time frame: t = 0, 1, 2 months) |
| Starting date | October 2009 |
| Contact information | Michael C Jecmen, MA, USA. Tel: 202‐745‐8000 ext 6236. Email: michael.jecmen@va.gov |
| Notes | Still recruiting participants |